GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.
This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations. Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
AZD0901 will be administered as an IV infusion.
Rilvegostomig will be administered as an IV infusion.
T-DXd will be administered as an IV infusion.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of perioperative treatment.
Time frame: Until sub-study completion, up to 38 months
Percentage of participants with pathological complete response (pCR)
pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.
Time frame: Until sub-study completion, up to 38 months
Surgery completion rate as planned
Surgery completion rate (including R0 and R1) as planned is defined as the percentage of participants who received intended gastrectomy or gastroesophagectomy as planned.
Time frame: Until sub-study completion, up to 38 months
R0 resection (complete resection) rate as planned
R0 resection (complete resection) rate as planned is the percentage of participants who received gastrectomy or gastroesophagectomy and had a confirmed margin-negative resection as planned.
Time frame: Until sub-study completion, up to 38 months
Percentage of participants with tumor downstaging
Tumor downstaging is defined as the lowering of the primary tumor (T) and/or regional lymph nodes (N) from pre-neoadjuvant clinical staging (pre-cTN) to post-neoadjuvant clinical staging (post-cTN) and to postoperative pathological staging (ypTN).
Time frame: Until sub-study completion, up to 38 months
Event-free survival (EFS)
EFS is defined as the time from the first dose of study intervention to documented Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or non-RECIST 1.1 disease progression that precludes radical surgery or requires non-protocol therapy during the neoadjuvant through surgery period, or to documented RECIST 1.1 or biopsy-confirmed non-RECIST 1.1 recurrence or progression of disease during the adjuvant period, or death due to any cause at any time.
AstraZeneca Clinical Study Information Center
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Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Research Site
Newark, Delaware, United States
NOT_YET_RECRUITINGResearch Site
Washington D.C., District of Columbia, United States
RECRUITINGResearch Site
Fairway, Kansas, United States
RECRUITINGResearch Site
North Shores, Michigan, United States
RECRUITINGResearch Site
New York, New York, United States
NOT_YET_RECRUITINGResearch Site
New York, New York, United States
NOT_YET_RECRUITINGResearch Site
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGResearch Site
Toronto, Ontario, Canada
SUSPENDEDResearch Site
Montreal, Quebec, Canada
NOT_YET_RECRUITINGResearch Site
Montreal, Quebec, Canada
RECRUITING...and 58 more locations
Time frame: Until sub-study completion, up to 38 months
Disease-free survival (DFS)
DFS is defined as the time elapsed from the date of the first post-surgery scan (ie, Adjuvant Baseline scan) until the date of first evidence of disease recurrence as determined by Investigator using RECIST 1.1 assessment (local or distant), or death due to any cause, whichever occurs first.
Time frame: Until sub-study completion, up to 38 months
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a CR or PR as determined by Investigator using RECIST 1.1 at their latest assessment prior to surgery.
Time frame: Until sub-study completion, up to 38 months
Overall survival (OS)
OS is defined as the time from the first dose of the study intervention until the date of death due to any cause regardless of whether participant withdraws from treatment or receives another anti-cancer therapy.
Time frame: Until sub-study completion, up to 38 months
Serum concentrations of study interventions
To assess the serum concentrations of study interventions in participants receiving perioperative treatment.
Time frame: Until sub-study completion, up to 38 months
Number of participants with positive anti-drug antibodies (ADA)
To assess the immunogenicity of study interventions in participants receiving perioperative treatment.
Time frame: Until sub-study completion, up to 38 months